Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-01 @ 9:50 AM
Study NCT ID:
NCT06802432
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall occurrence of postoperative AF', 'timeFrame': 'during the first 72 hours after cardiac surgery'}], 'secondaryOutcomes': [{'measure': 'length of the hospital stay', 'timeFrame': 'From the day of the surgery until the date of discharge from the hospital, up to 30 days.', 'description': "From the day of the surgery until the date of discharge from the hospital, which varies depending on the patient's clinical condition."}, {'measure': 'length of the ICU stay', 'timeFrame': 'from the day of the surgery ( postoperative ICU admission) until the time of transfer from the ICU to the surgical ward , up to 25 days.', 'description': "From the day of the surgery ( postoperative ICU admission) until the time of transfer from the ICU to the surgical ward , which varies depending on the patient's clinical condition."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Arrythmia', 'Anesthesia', 'Cardiac Surgery', 'Corticosteroids']}, 'descriptionModule': {'briefSummary': 'Cardiopulmonary bypass and cardiac surgery are associated with a significant systemic inflammatory response that has been suggested playing a causative role in the development of postoperative atrial fibrillation (POAF). The goal of this study is to determine the efficacy of corticosteroids prophylaxis in preventing POAF, or length of intensive care unit (ICU) or hospital stay.', 'detailedDescription': 'Most cardiac operations are performed under cardiopulmonary bypass, however, it is well known that cardiopulmonary bypass often causes systemic inflammatory response characterized by leukocyte and high levels of C-reactive protein (CRP) complexes, as well high levels of inflammatory mediators that may contribute to postoperative complications including atrial fibrillation (AF), prolonged duration of intensive care unit (ICU) and hospital stay.\n\nPostoperative atrial fibrillation has (POAF) been reported in 20% to 50% of patients following coronary artery bypass grafting (CABG) and is even higher after combined CABG and valve surgery.\n\nIt may increase stroke rates, trigger hemodynamic instability with heart failure and increase risk of thromboembolic complications.\n\nThe relationship between inflammation and atrial fibrillation after cardiac surgery is further strengthened by studies that showed that corticosteroid (CS) prophylaxis can reduce the occurrence of atrial fibrillation after cardiac surgery.\n\nCorticosteroids (CS) can reduce the risk of atrial fibrillation after cardiac surgery in adults and reduce length of intensive care unit (ICU) and hospital stay.\n\nIt is a low-cost drug that can effectively inhibit inflammation, limit systemic capillary leakage syndrome and reduce organ damage, thus providing a theoretical basis for its clinical application.\n\nHowever, the potential risks of CS remain controversial and inconclusive in terms of several side effects of CS such as hyperglycemia, gastrointestinal disturbances, and postoperative infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective first time CABG or combined with valvular surgery.\n* Use of b-adrenergic blockade.\n* Normal sinus rhythm.\n\nExclusion Criteria:\n\n* History of heart block\n* History of previous episodes of AF or flutter\n* History of peptic ulcer disease\n* Permanent pacemaker\n* Any documented or suspected supraventricular or ventricular arrhythmias\n* Renal insufficiency (serum creatinine \\>20 mg/dL)\n* Uncontrolled diabetes mellitus\n* Systemic bacterial or mycotic infection\n* Urgent or emergency surgery\n* Patient underwent cardiac surgery without using cardiopulmonary bypass'}, 'identificationModule': {'nctId': 'NCT06802432', 'briefTitle': 'Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Use of Corticosteroids on Prophylaxis of New-onset Arterial Fibrillation After Cardiac Surgery', 'orgStudyIdInfo': {'id': 'FMASU MS 716/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone (MP) group', 'description': '42 patients, given 1 g of methylprednisolone post cardiopulmonary bypass immediately postoperative', 'interventionNames': ['Drug: 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '42 patients, underwent a standard cardiopulmonary bypass without any additional medications'}], 'interventions': [{'name': '1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)', 'type': 'DRUG', 'description': '1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)', 'armGroupLabels': ['Methylprednisolone (MP) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Eman Elshaer, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine, ain shams university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia', 'investigatorFullName': 'Eman mohamed hesham elshaer', 'investigatorAffiliation': 'Ain Shams University'}}}}